The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Trypin (125i) Ria Kit.
| Device ID | K811805 |
| 510k Number | K811805 |
| Device Name: | TRYPIN (125I) RIA KIT |
| Classification | N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | JNO |
| CFR Regulation Number | 862.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-24 |
| Decision Date | 1981-08-31 |